Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight

Background & Aims: Gastric injections of botulinum toxin A (BTA) have been reported to delay gastric emptying, increase satiation, and reduce body weight, but there are few data from randomized, placebo-controlled studies. Methods: We enrolled 60 obese participants in a 24-week, double-blind, randomized, placebo-controlled, concealed allocation trial to compare the effects of gastric antral injections of BTA (100, 300, or 500 U) and saline placebo. The study was conducted at an outpatient clinical research unit. Participants were given one set of injections of BTA or placebo into the gastric antral muscularis propria by using endoscopic ultrasound guidance. Gastric emptying of solids was measured by scintigraphy; we also measured body weight, satiation (maximum tolerated volume in a caloric liquid drink test), calorie intake (by food frequency questionnaire), gastrointestinal symptoms, and psychological aspects of eating behavior (by rating scale). Results: Compared with baseline values, 2 weeks after injections, the mean half-time for gastric emptying of solids increased by 0.8, 14, 24, and 14 minutes among subjects given placebo, 100, 300, or 500 U BTA, respectively (P = .24 overall, P = .04 for the group given 300 U vs placebo); 16 weeks after the injections, mean body weights were reduced by 2.2, 0.2, 2.3, and 3.0 kg in these groups, respectively. There were no statistically significant differences in mean body weight change, satiation volume, caloric intake, gastrointestinal symptoms, or psychological aspects of eating behavior among groups. Conclusions: Gastric antral injections of BTA may delay gastric emptying at a dose of 300 U but do not cause early satiety, altered eating behaviors, or loss of body weight

Methodology of a multispecialty outpatient Obesity Treatment Research Program

Despite the large number of U.S. adults who overweight or obese, few providers have ready access to comprehensive lifestyle interventions, the cornerstone of medical obesity management. Our goal was to establish a research infrastructure embedded in a comprehensive lifestyle intervention treatment for obesity. The Obesity Treatment Research Program (OTRP) is a multi-specialty project at Mayo Clinic in Rochester, Minnesota designed to provide a high intensity, year-long, comprehensive lifestyle obesity treatment. The program includes a nutritional intervention designed to reduce energy intake, a physical activity program and a cognitive behavioral approach to increase the likelihood of long-term adherence. The behavioral intervention template incorporated the Diabetes Prevention Program and the Look AHEAD trial materials. The OTRP is consistent with national recommendations for the management of overweight and obesity in adults, but with embedded features designed to identify patient characteristics that might help predict outcomes, assure long-term follow up and support various research initiatives. Our goal was to develop approaches to understand whether there are patient characteristics that predict treatment outcomes. Keywords: Obesity, Weight loss, Intensive lifestyle program, Exercise prescription, Intensive lifestyle intervention, Individualized obesity treatmen